INVOKAMET XR

{
  "unii": {
    "unii": "0SAC974Z85",
    "rxcui": "1373458",
    "inchikey": "VHOFTEAWFCUTOS-TUGBYPPCSA-N",
    "display_name": "CANAGLIFLOZIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6868666b-c25e-40d1-9d1f-306bbe9390c1": {
      "match": "brand_token",
      "title": "INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED INVOKAMET XR (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "31",
      "published_date": "2025-08-25"
    }
  },
  "productid": "50458-942_3ce5755e-f0a3-692b-e063-6294a90a3c1f",
  "productndc": "50458-942",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205879",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;500MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG;1GM",
        "product_no": "002",
        "approval_date": "Sep 20, 2016"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "150MG;500MG",
        "product_no": "003",
        "approval_date": "Sep 20, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG;1GM",
        "product_no": "004",
        "approval_date": "Sep 20, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
  "proprietary_name": "INVOKAMET XR",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA205879",
  "marketing_category": "NDA",
  "nonproprietary_name": "canagliflozin and metformin hydrochloride",
  "start_marketing_date": "20160920",
  "active_numerator_strength": "150; 500"
}